Focused Ultrasound Success

The pioneering findings of the University of Virginia Health System’s trial of a scalpel-free form of brain surgery for reducing the hand shaking associated with essential tremor have been published by the prestigious New England Journal of Medicine.

Jeffrey Elias, MD

KEY FINDINGS:

Ultrasound can be focused through the scalp and skull without
surgery and with great precision, reducing tremor by creating a small
ablation (average size 3-5 millimeters) deep in the brain.

All participants reported substantial improvement in their quality
of life with essentially no residual disabilities from their tremor at
one year after treatment.

Reducing Hand ShakingEating is often extremely difficult for people with essential
tremor, the most common movement disorder. For many, enjoying a bowl of
cereal is impossible. Four participants in UVA’s trial could not
perform a simulated eating task prior to the procedure because of
severe tremor, but all four were able to do so after.

“We are very pleased to report these findings, and the publication
of the study in the New England Journal of Medicine validates the
significance of the study even though it is a very early stage
investigation,” said UVA’s Jeffrey Elias, MD, the
lead investigator of the study. “A project of this magnitude could only
be possible with the collaboration of large team of clinicians and
researchers. I am proud that UVA is committed to assembling the world’s
top neuroscientists to tackle a problem like this.”

The most common side effects reported in the trial were unsteadiness
or tingling in face or fingers, but these resolved or were mild. The
most serious adverse effect was a persistent uncomfortable sensation in
a single participant’s dominant index finger.

About Focused UltrasoundThe trial used focused ultrasound, guided by
magnetic-resonance imaging (MRI), to ablate a tiny aspect of the brain
circuit responsible for the tremor. More than 1,000 ultrasound waves
are focused to single site in the thalamus for the treatment — much
like a magnifying glass can generate heat by focusing light. Because
sound waves can pass through the skull, there’s no need for scalpels or
anesthesia. Another benefit of the approach is that it allows the
surgeon to target the sound waves very precisely and monitor their
effect throughout with MRI before delivering a permanent treatment to
the brain.

The focused ultrasound device used in the trial was InSightec Ltd’s
new ExAblate Neuro, which is under evaluation for this and other
indications.

Expanding the TestBased on their successful findings, UVA researchers have
partnered with InSightec to design a multicenter, international study
that is FDA-approved to further assess the safety and long-term
effectiveness of focused ultrasound in treating essential tremor. UVA
serves as the lead site for this large trial launching later this
year.

Elias is also conducting an initial clinical trial at UVA to test
focused ultrasound’s potential to reduce tremor in people with
medication-resistant Parkinson’s disease.

About the Tremor TrialAll treatments in the essential tremor study were performed at
the University of Virginia Focused Ultrasound Center, which was made
possible by a partnership of UVA, the Commonwealth of Virginia, the
Focused Ultrasound Foundation and InSightec.

“Treating the brain poses incredibly complex technical challenges,
and demonstrating that focused ultrasound may safely and effectively
target tissue deep in the skull is very promising for opening the door
to non-invasively treating other neurological disorders beyond
essential tremor,” said UVA’s Neal Kassell, MD,
chairman of the Focused Ultrasound Foundation. “In addition, by
starting to overcome the challenges of accessing and treating the
brain, we may advance the field to treat other organs, such as the
breast, liver, pancreas and prostate.”